Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients

NCT02755961 | Completed

• 1 other identifier: MED-SUR-15-147
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And most phosphate in human is derived from the food. The purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients.

Conditions

Hyperphosphatemia; End-stage Renal Disease

Keywords

End-stage renal disease; Phosphate binders; Hyperphosphatemia; Dietary education

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who reached Ca x P product lower than 55

  2-3 month

Secondary Outcomes (4)

• Changes of MMAS-8 score

  1 month, 2-3 month

• Changes of bioequivalent dose of phosphate binder

  2-3 month

• Changes of PG-SGA

  2-3 month

• Amount of change in dietary phosphorus intake

  2-3 month

Study Arms (2)

Control group

NO INTERVENTION

No intervention was performed

Education group

EXPERIMENTAL

Dietary education and education on phosphate binder use. Pharmacists instructed patients about how to take phosphate binders properly. Dietitians educated on dietary phosphate restriction.

Behavioral: Dietary education; Behavioral: Education on phosphate binder use

Interventions

Dietary education BEHAVIORAL

Education group

Education on phosphate binder use BEHAVIORAL

Education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-stage renal disease patients whose dialysis vintage is more than 3 months

You may not qualify if:

• Patients with liver cirrhosis
• Pregnant patients
• Patients with alimentary tract malabsorption diseases
• History of recent alcohol or drug abuse
• Patients receiving chemotherapy for solid organ tumor
• History of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.)
• Patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)

Sponsors & Collaborators

• Ajou University School of Medicine: lead

MeSH Terms

Conditions

Hyperphosphatemia; Kidney Failure, Chronic

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jong Cheol Jeong, MD

  Clinical Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: April 29, 2016
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 29, 2016

Record last verified: 2016-04